{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2020-11381", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20201219", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20201125", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20201219", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20200220", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1507437", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201219", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "M90200224", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201221", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)M90200224", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Detachment of Device or Device Component", "Break", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/22/2020;11/25/2020", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20201219", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20201125", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "11042993", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201125", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "321984071", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "4307 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. VISUAL INSPECTION FOUND TEARING AT THE MOUTH (DISTAL END) MEASURING APPROXIMATELY 0.122¿ TO 0.071¿ IN LENGTH. NO THERMAL DAMAGE WAS SEEN, AND NO MISSING PIECE WAS IDENTIFIED. THE TEARING PROPAGATED TO THE GREY SILICONE AREA OF THE MCS TIP COVER ACCESSORY. THE KNOWN COMMON CAUSE OF THIS FAILURE IS ATTRIBUTED TO REPEATED THERMAL AND MECHANICAL STRESSES. THE MCS TIP COVER ACCESSORY WAS INSERTED ONTO AN IN-HOUSE MCS INSTRUMENT AND THEN FUNCTIONALLY TESTED. THE MCS TIP COVER ACCESSORY HELD ITS PLACE AND DID NOT FALL OFF DURING FUNCTIONAL TESTING. THE INSTRUMENT PASSED ALL TESTING SPECIFICATIONS WITH NO ISSUE FOUND. THE CUSTOMER REPORT OF THE MCS TIP COVER ACCESSORY GETTING DETACHED AND FALLING OFF THE MCS INSTRUMENT WAS NOT REPRODUCED DURING EVALUATION. ADDITIONALLY, THE SECONDARY REPORT OF TEARING AT THE DISTAL END WAS CONFIRMED. THIS OBSERVATION IS INDICATIVE OF POTENTIAL ARCING." }, { "mdr_text_key": "335845990", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED." }, { "mdr_text_key": "335845991", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "234298525", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IMAGE REVIEW: A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE QUALITY OF THE IMAGE WAS POOR. THE IMAGE APPEARS TO SHOW DAMAGE ON THE DISTAL CLEAR SILICONE TIP (MOUTH) OF THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. FURTHER OBSERVATION AND A CONCLUSIVE DETERMINATION COULD NOT BE MADE BASED ON THIS ANALYSIS. ISI HAS NOT RECEIVED THE MCS TIP COVER ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. VERIFICATION OF THE ACCESSORY PRODUCT VIA SYSTEM LOGS COULD NOT BE PERFORMED BECAUSE ACCESSORY DEVICE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT DURING INTRAOPERATIVE USE. ALTHOUGH IT WAS RETRIEVED WITHOUT PATIENT HARM, ADVERSE OUTCOME OR INJURY, A FRAGMENT FALLING INSIDE THE PATIENT COULD POTENTIALLY RESULT IN AN ADDITIONAL SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY, WHEN USED AS INTENDED, PROVIDES INSULATION OVER A SECTION OF THE ENDOWRIST MCS INSTRUMENT SO THAT RADIO FREQUENCY (RF) ENERGY IS ONLY AVAILABLE AT THE INSTRUMENT SCISSOR TIPS. ADDITIONAL INFORMATION FROM THE CUSTOMER STATED THAT UPON INSPECTION OF THE MCS TIP COVER ACCESSORY, DAMAGE LIKELY EXTENDED INTO THE GRAY SILICONE AREA OF THE MCS TIP COVER ACCESSORY. A NEW MCS TIP COVER ACCESSORY WAS INSTALLED INTO THE SAME MCS INSTRUMENT TO CONTINUE THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. NO CUSTOMER ALLEGATION OF AN ARCING EVENT WAS REPORTED; HOWEVER, A DAMAGED MCS TIP COVER ACCESSORY COULD RESULT IN ARCING AND POTENTIALLY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR." }, { "mdr_text_key": "234298526", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY GOT DETACHED FROM THE MCS INSTRUMENT DURING INTRAOPERATIVE USE. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. ONCE RETRIEVED, INSPECTION IDENTIFIED DAMAGE ON THE DISTAL END OF THE MCS TIP COVER ACCESSORY. THE USER INSTALLED A NEW MCS TIP COVER ACCESSORY INTO THE SAME MCS INSTRUMENT AND CONTINUED THE PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO STARTING THE PROCEDURE AND PRIOR TO INTENDED USE. IT WAS NOTED THAT THE DAMAGE AT THE END OF THE MCS TIP COVER ACCESSORY APPEARED TO HAVE EXTENDED SLIGHTLY INTO THE GRAY PORTION. NO POST-OPERATIVE COMPLICATION HAS BEEN REPORTED AS OF THE DATE OF THIS REPORT. NO ISSUE WAS FOUND ON THE MCS INSTRUMENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/13/2021;05/24/2023" } ] }